BEUDAMED
    FDA Enforcement Class II Terminated

    Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

    Recall: Z-0832-2014 · Reported February 5, 2014

    Enforcement

    Recall Number
    Z-0832-2014
    Event ID
    67306
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2014
    Initiation Date
    December 9, 2013
    Classification Date
    January 27, 2014
    Termination Date
    May 29, 2014
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131, United States

    Description

    Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

    Reason

    Patient images exhibited ring artifacts.

    Code Info

    Brilliance iCT: 728306, Serial #'s: 100018, 100040, 100411, 100503, 100506 Brilliance iCT SP: 728311, Serial #'s: 200047, 200121

    Distribution

    Worldwide Distribution: US (nationwide) including states of: FL, IN, NY, OR and PA; and internationally to: Australia and Israel.

    Quantity

    7 units